NCT06871228Recruiting
Discontinuation of Anticoagulation With Intensive Rhythm Monitoring in Post-ablation Patients With Atrial Fibrillation
DIscontinuation of Anticoagulation With Intensive Rhythm MONitoring CompareD With Continuous Anticoagulation in Post-ablation Patients With Atrial Fibrillation: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 4 Mar 2026
Brief summary (registry, in English)
DIAMOND-AF is a multicenter, randomized, open-label trial evaluating whether discontinuing oral anticoagulation after successful atrial fibrillation ablation can reduce bleeding risk without increasing death or thromboembolism risks. Adults aged 18-80 years, 60-365 days post-ablation, with CHA2DS2-VA ≥2, no prior stroke/TIA/systemic embolism, continuous NOAC use, and no documented atrial tachyarrhythmia recurrence will be randomized 1:1 to stop NOACs immediately or to continue NOAC therapy. All participants use intensified rhythm surveillance including smartwatch ECG and Holter/patch monitoring (at least every 6 months; every 2 months encouraged) to detect recurrence. Co-primary endpoints are (1) non-inferiority for the composite of all-cause death, ischemic stroke, or systemic embolism and (2) superiority for the composite of ISTH major bleeding or ISTH clinically relevant non-major bleeding. The planned sample size is 4,100 participants.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 4100 (estimated)
- First submitted
- 26 Feb 2025
- Start date
- 5 Aug 2025
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Beijing Anzhen Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT06871228
What you commit to
- Study type: Interventional
- Planned participants: 4100
- From 5 Aug 2025 to the primary completion date, 31 Dec 2029
- 22 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior left atrial appendage (LAA) occlusion, surgical LAA excision/closure, or intraoperative confirmation of LAA electrical isolation.
Other illness
- Moderate-to-severe mitral stenosis (mitral valve area ≤2.0 cm²) or mechanical heart valve.
- Any condition requiring continued oral anticoagulation (e.g., pulmonary embolism, deep vein thrombosis, hypertrophic cardiomyopathy, cardiac amyloidosis).
- Conditions associated with high non-cardioembolic stroke risk, including carotid, vertebral, or intracranial arterial stenosis ≥70%.
- Any condition that, in the investigator's judgment, would make the participant unsuitable for the study.
Lab values
- Increased bleeding risk, including any of the following:
- Current ISTH major bleeding or clinically relevant non-major bleeding (CRNMB).
- History of non-traumatic major bleeding (e.g., intracranial, intraocular, spinal, retroperitoneal, gastrointestinal, or intra-articular) unless the reversible cause has been permanently eliminated.
- Unresolved intracranial aneurysm/vascular malformation, or active/unhealed gastric or duodenal ulcer.
- General anesthesia surgery within the past 3 months.
- Planned surgery within the next 3 months.
- Known bleeding diathesis (e.g., hemophilia).
- Uncontrolled hypertension (SBP \>180 mmHg and/or DBP \>110 mmHg).
- Hemoglobin \<90 g/L or blood transfusion within 4 weeks prior to enrollment.
- Platelet count \<50 × 10⁹/L.
- End-stage kidney disease (eGFR \<15 mL/min/1.73 m²) or on dialysis.
- Severe liver disease (e.g., esophageal variceal bleeding, ascites, hepatic encephalopathy, or jaundice).
- Known intolerance to oral anticoagulants or contraindication to oral anticoagulation.
Age
- Life expectancy \<2 years.
Other
- Participants will be excluded if any of the following criteria are present:
- High risk of post-ablation recurrence (e.g. including premature atrial contraction burden \>3% on any ambulatory ECG/Holter recording).
- Female participants who are pregnant or breastfeeding, or of childbearing potential not using effective contraception.
- Current participation in another interventional clinical trial.
Who the study is looking for
- Participants must meet all of the following criteria:
- Age 18 to 80 years.
- 60±15 to 365±15 days after atrial fibrillation/atrial flutter (AF/AFL) ablation.
- CHA2DS2-VA score ≥2.
- No history of stroke, transient ischemic attack (TIA), or systemic embolism.
- Continuous use of a NOAC since AF/AFL ablation.
- No documented atrial tachyarrhythmia recurrence since ablation.
- No antiarrhythmic drug (AAD) use within the past 2 months.
- Able and willing to provide written informed consent.
- Able and willing to comply with study procedures and follow-up.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Anzhen Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Not yet recruiting |
| Chengdu Fifth People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Not yet recruiting |
| First Affiliated Hospital of Dalian Medical University Coordinator of this site? Confirm its status | Dalian | China | Not yet recruiting |
| Guangdong Provincial People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Not yet recruiting |
| The First Affiliated Hospital of Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Not yet recruiting |
| The Second Affiliated Hospital of Harbin Medical University Coordinator of this site? Confirm its status | Harbin | China | Not yet recruiting |
| The First Affiliated Hospital of Harbin Medical University Coordinator of this site? Confirm its status | Harbin | China | Not yet recruiting |
| The First Affiliated Hospital of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Not yet recruiting |
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Not yet recruiting |
| Liaocheng Heart Hospital Coordinator of this site? Confirm its status | Liaocheng | China | Not yet recruiting |
| Liaocheng People's Hospital Coordinator of this site? Confirm its status | Liaocheng | China | Not yet recruiting |
| Luohe Central Hospital Coordinator of this site? Confirm its status | Luohe | China | Not yet recruiting |
| The First Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Not yet recruiting |
| Ningbo No.2 Hospital Coordinator of this site? Confirm its status | Ningbo | China | Not yet recruiting |
| Shengjing Hospital affiliated to China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Not yet recruiting |
| The Second Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Not yet recruiting |
| Wuhan Asia Heart Hospital Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
| The affiliated hospital of xuzhou medical university Coordinator of this site? Confirm its status | Xuzhou | China | Not yet recruiting |
| Henan Provincial Chest Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.